Category Archives: Ophthalmology

Final NHS nod for Roche’s RoActemra

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Roche/Chugai’s RoActemra should be routinely offered throughout the NHS to adults with giant cell arteritis (GCA) within the next three months, following a final green light from cost regulators.

Almost 15,000 patients develop GCA in the UK every year. The condition is a potentially life-threatening form of vasculitis that results in inflammation of blood vessels, which can be difficult to diagnose because of its wide range of symptoms, including severe headaches, scalp tenderness and jaw pain. If left untreated it can lead to blindness, aortic aneurysm or stroke.

To date, management of GCA has been limited to long-term high-dose steroids, but this can cause skin problems and weight gain, as well as diabetes and osteoporosis in the long-term. There have been no treatment advances for GCA for nearly 60 years.

RoActemra (tocilizumab) is an anti-IL-6 receptor licensed for the treatment of adult patients with moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis in children two years of age and older, and for the treatment of GCA in adults.

Clinical trial results show that after having RoActemra plus a tapering course of glucocorticoids for one year, more people stay in remission and need lower doses of glucocorticoids compared with people having glucocorticoids alone.

The National Institute for Health and Care Excellence is recommending funding for one year’s treatment with the drug for patients who suffer flares of their GCA or may not respond fully to steroids, as their disease is most difficult to control.


AI predicts heart attack risk factors from retinal scans

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Artificial Intelligence can be used to predict heart attack risk using retinal images, according to new research backed by Google.

The researchers trained deep learning algorithms on data from thousands of patients recorded in a massive UK study, which was used with retinal scans to produce a program that can identify risk factors from the scan information alone.

This predicted cardiovascular risk factors not previously thought to be quantifiable using retinal images: these included age, gender, smoking status, gender, systolic blood pressure and major adverse cardiac events.

Reporting results in the journal Nature Biomedical Engineering, the team used a dataset from the UK’s Biobank, a study where 500,000 were recruited between 2006 and 2010, and agreed to have certain health measurements recorded.

Health outcomes such as hospitalisation, mortality and cause of death were also logged. Smoking status was obtained via survey using a touchscreen interface in the research backed by Google and Verily, Alphabet’s healthcare subsidiary.

Participants were also asked to identify whether they are a current smoker, former smoker, or had never smoked, and blood pressure readings were also taken.

A further 67,725 had paired images of their retina fundus taken, along with a second group that was used to create a training dataset with known risk factors.

The researchers asked a neural network to make an output prediction based on the fundus image.

It was able to analyse images from the group with unknown risk factors, compare it with the training data set and after the process was repeated, was eventually able to predict cardiovascular risk factors from new images.

This is just the latest in a series of studies showing the potential of AI to predict healthcare outcomes, saving lives and reducing costs by ensuring patients receive timely and sometimes life-saving treatments.

Early last month, the government’s life sciences tsar, Sir John Bell, said that similar techniques could save the NHS billions.

A team at Oxford’s John Radcliffe Hospital is using AI to identify abnormalities in ECG read-outs that could be missed by the human eye, for instance.

The hope is that this system could be used in hospitals across the country to prevent unnecessary hospitalisations caused by false positives, and prevent heart attacks where at-risk patients are sent home because doctors have failed to spot problems.

Another AI system outperformed a panel of experts when asked to diagnose breast cancer based on stained tissue samples, in a separate study published in the Journal of the American Medical Association last month.


Federal court quashes Allergan eye drop patents

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Ruling negates company’s deal with Mohawk tribe to avoid patent board review

A US federal court has ruled that four patents relating to Allergan’s Restasis (ciclosporin) eye drops are invalid. The ruling opens the way for challengers Mylan and Teva to introduce generic versions. Allergan has said it will appeal the decision.

The ruling renders Allergan’s transfer of these patents to the St Regis Mohawk tribe null and void – Allergan intended the deal to shield the company from a parallel challenge through the US Patent and Trade Office, by employing the Native American tribe’s sovereign immunity from such challenges.

At the same time, Allergan had struck a deal with Pfizer subsidiary Innopharma to resolve litigation over the same patents. Allergan has granted Innopharma a license to market a generic cyclosporin eye treatment in the US in February 2024 – about six months before its patents were due to expire – or earlier under certain circumstances. It is unclear how the court’s ruling would affect this deal.

Allergan noted in a statement that neither Mylan nor Teva has yet received regulatory approval for their generic cyclosporine eye drops. However, both companies already produce the drug in capsule form, and the ruling clears the way for them to be launched as soon as they are approved.


Shire sues Allergan in U.S. over dry eye drug

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(Reuters) – Allergan Plc was sued on Monday by Shire Plc for allegedly scheming to block doctors from prescribing its new treatment for dry eye disease.

In a complaint filed with the federal court in Newark, New Jersey, Shire accused Allergan of violating antitrust laws to preserve its roughly 90 percent share in Medicare prescription drug plans for its older and “clinically inferior” dry eye drug Restasis, and block prescriptions of Shire’s rival drug Xiidra.

“Quite simply, Allergan has and will continue to use bundled discounts, exclusive dealing, coercion and interference to unlawfully ‘block’ Shire from competing with it, and to maintain its monopoly in the Part D market at all costs,” Shire said, referring to the Medicare drug plans.

The lawsuit follows Allergan’s announcement on Sept. 8 that it transferred its Restasis patents to the Saint Regis Mohawk Tribe in upstate New York, whose sovereign status could limit legal challenges. The Tribe subsequently agreed to license the patents to Allergan.

Four U.S. senators last week called for a probe of whether the unusual move was anti-competitive and intended to keep prices high.

Restasis is Allergan’s largest drug other than Botox, with sales of $1.49 billion in 2016 and $676.4 million in the first six months of 2017, regulatory filings show. Shire has said Xiidra sales totaled $96 million from January to June.

Allergan spokesman Mark Marmur said the lawsuit has no merit, and the company complies with Medicare procedures.

“Competition in the chronic dry eye therapeutic market has driven pricing down for patients and payers in Medicare Part D and commercial plans,” he said in an email. “Restasis continues to provide significant value to Medicare beneficiaries, providers and the Part D program.”

Dry eye occurs when the eye produces tears improperly or with the wrong consistency. Failing to treat it can lead to inflammation, scarring and even vision loss. The condition is often chronic, and affects nearly 16 million U.S. adults.

Allergan and Shire are headquartered in Dublin, Ireland, although Allergan has operations in Parsippany, New Jersey, and Shire in Lexington, Massachusetts.

Shire won U.S. Food and Drug Administration approval in July 2016 for Xiidra, the first dry eye disease drug to win FDA approval since Restasis in 2002.

The chemical name for Restasis is cyclosporine, and for Xiidra it is lifitegrast.

The case is Shire US Inc v Allergan Inc et al, U.S. District Court, District of New Jersey, No. 17-07716.